• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, nerve
510(k) Number K040543
Device Name NUVASIVE NEUROVISION JJB SYSTEM
Original Applicant
NUVASIVE, INC.
10065 old grove rd.
san diego,  CA  92131
Original Contact laetitia bernard
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
INK  
Date Received03/02/2004
Decision Date 04/01/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-